PHR Stage 2 Guidance - Application Development Award
Application form guidance notes for applicants submitting Stage 2 applications (specific to the 20/69 call for Application Development Award - IPEDs).
This guidance should be used by applicants who have either:
1) been shortlisted at Stage 1 and asked to submit a Stage 2 application.
2) by those applying for a specific call where a single stage, straight to Stage 2 application has been requested as part of the call. Typically for an Evidence Synthesis or fast-track proposal.
*For shortlisted applicants, the fields indicated with an asterisk will be automatically populated in the Stage 2 form with content input to the Stage 1 form. This content is editable and should be updated in line with any changes made to the application following feedback from the board at Stage 1.
Application Summary Information
Please give details of the organisation who will be the contractor if the project is funded.
Please note that we expect the Chief Investigator’s host organisation (substantive employer) to act as the contractor.
Please also bear in mind that:
- Thought must be given to the most appropriate institution to act as the contractor as part of the application process, as changes are unlikely to be agreed once a funding decision has been made.
- The contractor is expected to respond to annual financial reconciliation exercises, provide the final financial reconciliation statement for the project and to provide ad hoc requests for financial information during the lifetime of the project. In the unlikely event that a request is made for the contractor to differ from the CI’s host institution, the suggested contractor must be able to fulfil these expectations and to do so in the usual time-frames.
- In the same way, the contractor is expected to respond to any queries relating to Intellectual Property, commercialisation and benefit realisation.
If you have any queries, please contact email@example.com before submitting your application.
It is sufficient to put ‘Application Development Award – Image and Performance Enhancing Drugs (IPEDs)’
Select the appropriate research type. If your proposed project includes any element of primary research (collection of data), 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
Please put 1 December 2020. Teams will be expected to be contracted and commence the project during December 2020.
Research Duration (months)
This contract will be for a total of 6 months.
This field will automatically populate once you have saved the research duration information.
Total (Stage 2) Research Costs
Automatically populated from detailed budget section. The contract is for a maximum of £50,000.
Total (Stage 2) NHS Support and Treatment costs or external (not NHS) intervention costs
Automatically populated from detailed budget section. This should be £0.
Total non-NHS intervention costs
This should be left blank for this application.
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, Joint Lead and Co-applicants Details / CV
Complete your name, contact details and other requested information
Please note: You are required to obtain a free unique ORCiD ID number and update your MIS user profile with this before you can submit your application. By clicking the link ‘View ORCiD record’ 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 be returned to the MIS and the profile field for your ORCiD number will automatically be populated. You will only have to do this once. For a Stage 2 application this is a mandatory requirement.
If your proposal includes PPI co-applicants, we are interested in their knowledge, skills and experience that are relevant to this application. They are not required to provide a full CV (i.e. N/A may be appropriate for Publication Record and Research Grants held).
We recognise and value the varied perspectives that members of the public, patients and carers bring to a project as applicants. In this section, PPI co-applicants should provide a summary of any relevant knowledge, skills and experience that they will draw upon to contribute to this project.
This could include information about:
- Previous or present work (paid or unpaid) with any relevant organisations
- Links with any relevant groups, committees, networks or organisations
- Experience of particular health conditions, treatments, use of services - or as a member of a particular community
- Knowledge and experience of research including previous research undertaken
- Knowledge and experience of patient and public involvement including previous involvement activities
- Skills from any other roles that are transferable
- Relevant qualifications, training and learning
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.
Research Background – Lead, Joint Lead and Co-applicants
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
This should include research grants held (as a named applicant) currently or in the last five years – as well as any additional previous grants, relevant to this application. Please include the name of the funder 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.
History of Application - Has this application been previously submitted to this or any other funding body? (completed by Lead Applicant only)
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 (completed by Lead Applicant only)
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 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 applicable) 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 Detailed Research Plan section/upload 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 who do not share in the responsibility for the delivery of the project.
Guidance for how co-applicants complete their sections can be found on the MIS help page
Your application must be submitted, including the co-applicant’s section, by the closing date and time for the call. Please note that any out of offices or undeliverable messages from the co-applicant’s mailbox will be received by an unmonitored email account at NETSCC
Other supporting roles – signatories (electronic)
Other supporting roles This is a stage 2 application submission requirement but will not appear on Board/committee member version of the application form
As a minimum the following (mandatory) supporting roles are required to be added to a full proposal application:
1. Administrative Authority or Finance Officer
2. Head of Department or Senior Manager Sponsor
If you, the lead applicant, are also signing as Head of Department you should not complete this signatory task until you are ready to submit your application form. Once the lead applicant completes the Head of Department signatory task, various fields within the application form will become non-editable.
In addition other listed supporting roles should be added as necessary. At the time of adding the necessary supporting roles required to approve your application you are advised to inform the Trust R&D office of the site most likely to be the lead site for your proposed research. The aim is to help speed up the permissions process should your application be successful. Please note this will not apply to all proposals.
4. Representative of the R&D Function of the Devolved Country
For research projects originating in Scotland, Wales or Northern Ireland, we will require evidence of support with regards to NHS support and treatment costs (where applicable). The nominated signatory for this section should be an authorised person on behalf of the Public Health Agency in Northern Ireland, the NHS Health Scotland or the R&D office in the lead NHS organisation in Wales. By signing the form, the signatory is agreeing that the excess treatment costs and support costs stated in this application appear reasonable.
Each person nominated to a supporting role will be required to tick a check box indicating that they have read and understood the terms on which they have been nominated for this proposal and accept this role. Ticking this box constitutes an electronic signature of the supporting role with regard to this full proposal application.
Once the application form is completed and prior to submission the Lead Applicant is also required to tick a check box to indicate that they have read and understood the terms on which you have been nominated as Chief Investigator for this proposal along with the associated documentation and accept this role (see acknowledgement section).
No original signatures are required for this application.
Scientific Abstract (limit 3,500 characters)
The scientific abstract should be a clear and concise scientific summary of the Detailed Research Plan / Methods, with a word limit of 500 words (one side of A4 maximum). Please ensure your scientific abstract addresses the aims outlined in the specification document.
Plain English Summary
The importance of a plain English summary (limit 3,500 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 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 board and panel members) to have a better understanding of your research proposal
- Inform others about your research such as members of the public, health 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 / members of the public in developing a plain English summary.
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
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.
For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable).
Changes from First stage
Changes from first stage (limit 3,500 characters)
Please note, as you are submitting a one step, straight to Stage 2 proposal please ignore this question as it is not applicable to you. Please enter ‘not applicable’ in the box.
Please describe how patients and the public have been involved in developing this proposal (limit 3,500 characters)
You should describe who has been involved and why this is appropriate, what role(s) they have they played and what influence or change has happened as result of their involvement.
Please describe the ways in which patients and the public will be actively involved throughout the proposed research, including any training and support provided (limit 3,500 characters)
Patients and public can be involved in every stage of a research project, from developing a proposal through to dissemination and evaluation. In your description you will need to say who will be involved and why.
Explain why your approach to public and patient involvement is appropriate for this proposal.
Describe how you will support and enable patient and public involvement in your research (e.g.: payments, training).
In rare cases where proposals do NOT involve patients and the public, clear justification must be provided. (limit 3,500 characters)
Complete / justify as necessary.
Justification of costs
- Please provide a breakdown of research costs associated with undertaking the research and provide justification for the resources requested. This should include the following costs: staff costs, travel and subsistence, dissemination costs, equipment (including lease versus purchase costs), consumables, patient and public involvement (PPI) and any other direct costs. For help with estimating PPI costs please see the INVOLVE cost calculator
- When justifying staff costs you should also provide the % amount of time input of each member of staff and link this to the specific area/work package of the proposed study where this input will be taking place.
- You should indicate here how this research will potentially benefit the NHS and/ or public health. For example, where appropriate, describe the likely cost savings or benefits in terms of numbers of patients treated, treatment times etc.
- You should describe the value for money of the conduct of the proposed research.
- Please provide a breakdown of the NHS costs associated with undertaking the research and provide justification for the resources required. If there are no NHS Support or Excess Treatment Costs associated with the research you must explain why you think this is the case.
- Please provide a breakdown of any non-NHS intervention costs and provide justification for the resources required. Non-NHS intervention costs should include costs incurred in delivering the intervention which would continue to be incurred after the trial, should the intervention become 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.
Detailed Budget Breakdown
The finance section should provide a breakdown of costs associated with undertaking the research as described in the proposal.
The information entered in this section should provide an analysis of the total funds requested to undertake the research proposed and should be based on current prices. These costs will be used to assess value for money.
- It is in the best interest to undertake a thorough, realistic and accurate costing. Where an outline/stage 1 application has been produced and this is the full stage (2) application, the Committee/Panel will pay close attention to any material increase in costs. You must provide a clear and full justification for all costs including NHS costs. You must also ensure that you include all costs including those required to secure good research management.
- Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by the Department of Health. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded.
- Years should be calculated starting from the anticipated start date of the proposed research. For example, if your research is expected to start on 01 June 2020 then its second year starts 01 June 2021.
- Further itemisation of costs and methods of calculation may be requested to support the application at a later date.
- Payments will be made to the contracted organisation only and the contracted organisation will be responsible for passing on any money due to their partner organisation(s).
- Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
- NHS Support Costs are funded via Clinical Research Networks. Researchers should contact their local NHS R&D Department initially and, if they are unable to help directly or if there is no local NHS R&D Department, contact the Local Clinical Research Network Senior Manager for advice on NHS Support Costs. Further details about LCRN contacts
- All applications are expected to have appropriate NHS, HEI, commercial and other partner organisation input into the finance section of the application form.
- Please note that whilst the applicable percentages will be used to calculate the maximum grant payable, the programme reserves the right to award a grant for less than this maximum where it is considered appropriate.
Costs for un-named co-applicants
- If you need to provide costs for more than one unnamed individual it is important to name them as ‘TBA 1’, ‘TBA 2’ etc. not just ‘TBA’, otherwise their costs will not appear in the PDF version of the form.
INFORMATION ON DIFFERENT TYPES OF ORGANISATIONS
Higher Education Institutions (HEIs)
- Higher Education Institutions (HEIs) should determine the Full Economic Cost (FEC) of their research using the Transparent Approach to Costing (TRAC) methodology. For HEIs, up to 80% of FEC will be paid, provided that TRAC methodology has been used.
NHS bodies and other providers of NHS services in England
- For applications where the contractor is an NHS body or provider of NHS services in England, up to 100% of direct costs will be paid.
Other Partner Organisations
- If you are a commercial organisation/consultancy, please fill in direct costs and commercial indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.
- If you are an ‘other partner’ organisation (e.g. charity or NGO), please fill in direct costs and other partner organisations indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.
These are costs that are specific to the research, which will be charged as the amount actually spent and can be supported by an audit record. They should comprise:
Posts and Salaries Summary
This section presents an overview of salary and associated on-costs for the applicant(s) contributing to the research, including normal salary increments broken down individually.
Please include all members of staff working on the research by clicking ‘add a new staff member’ or editing a current one. If there are any applicant(s) whose costs are not being claimed you should still include their details within this section, but don’t include any actual costs. Where applicants are already in receipt of NIHR funding for any part of their salaries (e.g. NIHR Fellowships), these should not be additionally charged to the project. Where applicants are already receiving salaries funded by NIHR, these should be declared in the application.
The Apprenticeship Levy can be included in the salary costs from 1st April 2017 where relevant.
Apply to years
This section specifies the annual costs of each applicant contributing to the research. You should now allocate the individual staff member costs to each year of the research, allowing for increments. Use current rates of pay, and build in any known annual increments (again at current rates). You will not be able to claim for pay awards retrospectively, once your research is underway.
Please note the ‘Total Salary’ column figures need to be calculated using the current annual costs, %FTE and number of months. If the research lasts for several years and an individual’s involvement varies over the course, it may be necessary to explain fully in the justification of costs section the % FTE and months per year for an individual staff member.
It is important to double check that the % FTE, total months and yearly costs information are consistent with the information presented in ‘Details of Posts and Salaries’ (‘Details of Posts and Salaries’ should show the full current staff costs independent of % FTE etc., whereas the yearly costs in ‘Annual Costs of Posts’ depend on % FTE etc.).
Please ensure that you check the ‘Type of Cost’ box which describes the employing organisation for a member of staff as this impacts on the level of funding provided. Staff employed by a Higher Education Institution (HEI) are funded at 80% of cost and staff employed by NHS, commercial or other partner organisation at up to 100% of cost.
Please note that this section also includes ‘Shared Staff Costs’ which is located under directly allocated costs in some other funders’ applications. These are costs of an institution’s research resources which can be charged to the research on the basis of estimated use, rather than actual costs. These may include: IT technicians, laboratory staff, and costs of pooled staff efforts. HEI indirect costs cannot be claimed on these shared costs.
Travel, Subsistence and Dissemination costs
This section includes journey costs, subsistence and dissemination costs, including conference fees and open access publication costs. Where applicable, you will need to include the travel and subsistence costs of your Project Advisory Group, Steering Committee and/or Data Monitoring & Ethics Committee. Travel and subsistence costs relating to dissemination should also be included here, as should costs relating to overseas travel.
Enter the total cost of transport for all journeys for destination/purpose. If travel is by car, apply your institution’s mileage rates (however this should not exceed HMRC approved mileage allowance payments, which is 45p per mile for the first 10,000 miles and 25p thereafter).
Travel by the most economic means possible is encouraged. NIHR programmes do not usually fund first class travel.
Subsistence covers accommodation (if necessary) and meals associated with the travel, excluding any alcoholic beverages.
Where national or international conference costs are included, a statement naming the conference or purpose of travel and the benefit to the research must also be made; failure to adequately justify your attendance at a conference, will mean the programme will not fund this cost.
For research of up to five years, the programme will usually fund up to a maximum of two individuals to attend one international conference, or one individual to attend two international conferences. For research beyond five years, the programme will usually fund up to a maximum of two international conference attendances per five year or part of five year research period.
Open Access Costs
During the course of your project and throughout review and publishing phase you may choose to submit an article based on your research to an Open Access publication.
Depending on the publication you may be subject to an article processing charge (APC). APC rates vary but are usually within the range of £300 and £3000. Open Access publications usually list their APC rates on their websites.
Where possible you should include an estimate for any APC in your funding application, since NIHR expects that APCs will be covered by the funding award.
Other Dissemination Costs
Any large costs should be further detailed with a breakdown of constituent parts or a timescale profile of the costs. Meetings to share best practice, training events and events to disseminate research findings must be run at the lowest possible cost with minimal catering. ‘Conferences’ which are described as such are not eligible for funding.
Essential items of equipment plus maintenance and related costs not included as part of estates should be input in this section. These can be lease or purchase costs. The purchase cost of pieces of equipment, valued up to £5,000 excluding VAT, will be considered.
Pieces of equipment costing more than £5,000 to purchase will usually need to be leased. Where applicants are leasing equipment with a purchase price of more than £5,000, a comparison of leasing verses purchasing costs must be provided in the ‘Justification of Costs’ section.
Items of equipment valued at £250 or more must be itemised separately; however grouping same type equipment is permitted. Costs of computers are normally restricted to a maximum of £650 each excluding VAT and a statement of justification must be included, in the relevant ‘Justification of Costs’ section for any purchase above this limit.
Equipment must exclude VAT, but if your organisation is unable to reclaim/recover the VAT on a piece of equipment, you should check the box ‘VAT cannot be reclaimed’.
You will need to seek expert advice from the organisation purchasing the equipment regarding its VAT status. If you check the ‘VAT cannot be reclaimed’ column, VAT at 20% will automatically be calculated into the overall cost of that item.
This section includes non-reusable items specific to the research. Please itemise and describe the requirements fully (e.g. postage, stationery, photocopying). These items should be research specific, not just general office costs which should be covered by indirect costs.
Patient and Public Involvement
Please itemise and describe fully the costs associated with Patient and Public Involvement. These are likely to include out of pocket expenses, payment for time and any relevant training and support costs.
INVOLVE have produced a number of useful payment-related resources
Other Direct Costs
These are costs, not identified elsewhere, that are specifically attributed to the research. For example, costs associated with the use of research facilities, external consultancy costs, computer licensing, recruitment and advertising costs. Please note that for organisations claiming indirect/overhead costs, costs such as recruitment of staff, and general training (e.g. in common IT packages) are costs that should be covered by the indirect costs element of the award being sought and should not appear in this section.
If external consultancy costs are included in this section they must be fully justified in the ‘Justification of Costs’ section. Please specify the hourly rate and the number of hours and note that consultants must not be people who are already employed by the applicant’s institution. If they are, any costs should be entered as direct costs in the ‘Details of Posts and Salaries’ and ‘Annual Costs of Posts’ sections.
Indirect costs will be charged in proportion to the amount of research staff effort requested on the award. Commercial/Other Partner Organisations should calculate them, using their own cost rates.
- General office and basic laboratory consumables
- Premises costs
- Library services/learning resources
- Finance, personnel, public relations and departmental services
- Usage costs of major research facilities
- Central and distributed computing
- Charge out rates for shared equipment
- Cost of capital employed
NHS Bodies or other providers of NHS services indirect costs
NHS Indirect Costs cannot be claimed through NIHR/DH programme funding. NHS Bodies or other providers of NHS services have been allocated NIHR Research Capability Funding (RCF) to contribute to the cost of hosting NIHR/DH-supported research.
HEI Indirect Costs
Total HEI indirect costs must be fully justified. HEIs are permitted to claim estate and other indirect costs. These costs are calculated on the basis of TRAC methodology. Proposals from other types of institutions/organisations should leave this section blank.
HEI indirect costs are based on the number of full-time equivalent research staff working on the research and the indirect/estates charges set by an institution. Please note HEI indirect costs cannot be claimed on shared staff costs. Where staff from more than one HEI are working on the research there may be different indirect/estates charges for each one. Please list each institution on a separate line.
The applicant(s) should consult their HEI Finance Departments for the appropriate figures to include in the estate charges and other indirect cost sections
Commercial/Other Partner Organisation Indirect Costs
Commercial/Other Partner Organisations can claim indirect costs which are the costs of resources used by the research that are shared by other activities. Please seek advice from your finance department about the appropriate cost for this section.
Total Commercial/Other Partner Organisation indirect costs must be fully justified.
NHS Support and Treatment Costs (incl. Excess Treatment Costs/Savings)
The finance section includes a section that asks researchers to provide an estimate of the patient care costs associated with the research (if applicable). An explanation of why these costs are being incurred and the basis on which the estimations have been made should be fully detailed under the relevant ‘Justification of Costs’ section.
The Committee/Panel will take NHS Support and Treatment Costs into account when considering the value for money of the research. It is important that you consider these costs and discuss them with the NHS bodies or providers of NHS services involved in order to avoid any delay in commencing the research.
Please be aware that the research award does NOT include NHS Support and/or Treatment Costs. NHS Support Costs will be funded via the Comprehensive Research Networks. NHS Treatment Costs, including any Excess Treatment Costs/Savings, will be met by the NHS through normal patient care commissioning arrangements.
NHS Support Costs
These are the additional patient care costs associated with the research, which would end once the R&D activity in question has stopped, even if the patient care service involved continues to be provided. These might cover items such as extra patient tests, extra in-patient days and extra nursing attention. Researchers should contact their local NHS R&D Department initially and, if they are unable to help directly or if there is no local NHS R&D Department, contact the Local Clinical Research Network Senior Manager for advice on NHS Support Costs.
NHS Treatment Costs
Please read the guidance on funding of excess treatment costs prior to completing your application .
These are the patient care costs that would continue to be incurred if the patient care service in question continued to be provided after the R&D activity has stopped. In determining NHS Treatment costs you must assume that the patient care service being assessed will continue even though there may be no plans for it to do so. Where patient care is being provided which differs from the normal, standard, treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given), the difference between the total Treatment Costs and the costs of the “usual standard care" (if any) constitutes Excess Treatment Cost/Saving, but is nonetheless part of the Treatment Cost, not an NHS Support or Research Cost. These costs should be determined in conjunction with your NHS body or provider of NHS services and their commissioners.
Please note if the patient care intervention under investigation is in addition to usual care there is no need to complete the ‘Usual Treatment Costs’ section however this will need to be justified in the relevant ‘Justification of Costs’ section. If the patient care intervention under investigation either wholly or partially replaces usual care, the ‘Usual Treatment Costs’ section must be completed.
For further information, please see:
Management and Governance
Is Clinical Trials Authorisation required?
Yes / No
Does your project require ethics approval?
Yes / No
If yes, has ethics approval already been obtained?
Yes / No
ATTACHMENT 1: Detailed Research Plan - It is mandatory to upload and submit a Detailed Research Plan (DRP), which is a full account of the proposed project.
- Use Arial font size 11
- Not exceed 6 A4 pages (not including references)
- Margin widths should be no less than 2cm
- Have a header containing your allocated project reference number if known
- Have a footer showing your page numbers
- Be converted to a .PDF version before uploading it
Broadly, the detailed research plan should follow the following structure:
Headings / guidance
Full title of project
It is sufficient to put ‘Application Development Award – Image and Performance Enhancing Drugs (IPEDs)’ and then something specific about the focus of the proposed study.
Background and Scientific Rationale
This section should include a brief literature review of published evidence as well as a review of ongoing research, outlining what is already known and research that is currently underway. Applicants should outline the methods that they have used to do this review and list databases searched and search terms used.
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.
This scheme aims to provide funding for underpinning development work that will add to the current knowledge base on IPEDs use, and will ultimately support and inform applications to the IPEDs intervention effectiveness commissioned call. This aim should be the basis of your research question.
Research Plan / Methods
Please refer to the call page specification document when writing your research plan. Please ensure you consider and articulate how this work will aid an application in response to the IPEDs intervention evaluation commissioning brief when it is launched in 2021.
Outline the design of your research ensuring your methods and fieldwork are clearly connected to the aims and objectives and research questions you outlined earlier. Ensure that the aim of your research is in line with that described in the specification document.
Elements of exploration could include:
- Identification and engagement of relevant stakeholders. For example, with specific communities, policy makers, occupation groups.
- Development of networks or partnerships. For example, across or within particular geographical areas, service delivery organisations, patient/user and carer experience groups or settings where IPED use may occur.
- Local or regional needs assessments to identify priorities for future research.
- Understanding of what data is collected on IPED use. For example, data collected by dedicated IPED services, substance misuse services or other statutory organisations such as prisons.
- Underpinning research such as epidemiology. For example, investigations of prevalence within specific population groups or broader epidemiological assessments that may inform intervention research. This could include attention given to the scale, types and pattern of use, demographic patterns of use, predictors of use, settings, concurrent health-related and/or other behaviours.
- Analysis of how current interventions to prevent substance misuse may be used for IPEDs and consideration of possible new approaches.
Applicants should ensure that the development work includes recognition of possible interventions and approaches to preventing or reducing the health harms caused by the use of IPEDs.
In this section you need to ensure that the cost of each stage of your research is understood and that these are clearly indicated. Justification of these costs is required elsewhere, please do not set these out in this section.
You may like to consider some of the following headings when describing the research you wish to undertake, they may not all be appropriate;
- Search strategy (in the case of projects involving evidence synthesis): Provide details of preliminary searches, the body of existing evidence that will be covered, access arrangements (e.g. use of databases, hand-searching, communication with authors, etc.) and the search and review strategy. The databases you wish to use need to be specified and the team’s ability to access them commented on.
- Strategy for reviewing literature (in the case of projects involving evidence synthesis): Explain the criteria to be applied to assess the quality and relevance of studies identified by the search strategy. Provide an explanation of how these will be decided if they are not yet known. Describe your methods for combining, aggregating or synthesising research findings and different forms of evidence.
- Design and theoretical/conceptual framework: Please provide a clear summary of the study design, including all of its components and relevant time points 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.
- Intervention(s): you should include details of any intervention(s) under consideration.
- Setting/context: Please describe the setting or context in which the study will take place.
- Study population: which population(s) will be the subject of the research? How will the population(s) be recruited and retained? How will they be engaged with?
- Outcome measures: please state and justify the primary and secondary outcome measures where appropriate. Validated surrogate markers are acceptable where appropriate.
- Methods for data collection: please state the method of data collection, including qualitative methods where appropriate.
- Data & Statistical analysis: 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.
- Socioeconomic position and inequalities: A summary of how your proposal will take into account the socioeconomic position of the research participants and potential participants should be included, as well as a description of how the research will attempt to address inequalities. Please detail if and how the study will measure the distributional impacts of the intervention (You may like to refer to PROGRESS-Plus characteristics).
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
- Gender reassignment
- Marriage and civil partnership
- Pregnancy and maternity
- Ethnicity - see the toolkit for increasing participation of BAME groups in health and care research
- Religion or belief
- 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.
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.
Dissemination, Outputs and anticipated Impact
The expected output from this award would be a report describing the findings that will be used by NIHR and DHSC to inform ongoing discussions in this area. The output will include both a written report which will be published on the NIHR Journal’s website. This report will be delivered by 1st June 2021.
What do you intend to produce from your research?
In addition to that stated in the output section of the specification document please consider other possible outputs here.
NB the term ‘outputs’ refers to any tangible product of the research, not just academic publications. Outputs can include but are not limited to: Conference presentation or other workshop events; Publications (academic or otherwise); Guidelines (clinical, service or otherwise); Other copyright (e.g. questionnaires, training aids, toolkits, manuals, software, etc); New or improved design of devices or instrumentation; New or improved diagnostic; Outcome data that could be used to support a CE mark, market authorisation or equivalent; Trial data that could be used to shape or influence a healthcare market or government; Potential new public health intervention.
What do you think the impact of your research will be and for whom?
In addition to that stated in the output section of the specification document please consider the above question.
Describe the impacts you aim to achieve as a direct result of the project and those which are anticipated longer term. Please consider how any smaller, more immediate effects may mature over time into larger scale or more significant effects, and the steps by which this may be achieved. As far as possible, indicate anticipated timescales for these benefits and a quantitative estimate of their scale. Impacts may include, but are not restricted to - patient benefit; healthcare staff benefits; changes in NHS service (including efficiency savings); changes to public health services, change to public health policy or policies in other sectors, commercial return (which could contribute to economic growth); public wellbeing.
Project / research timetable
The planned project should run from 1 December 2020 – end May 2021 with a final report being delivered by 1st June 2021
Please provide a concise summary here of the project plan of investigation, preferably in the form of a monthly project timetable showing the scheduling of all key stages in the project, their expected durations, and the timing of key milestones throughout the project including the production of outputs.
Please ensure your timings (e.g. time allowed for securing ethics/governance approval, for undertaking data collection and analysis, and for reporting and writing up) are realistic.
This timetable will be an important aspect of the monitoring framework during the life of the project.
If your application is successful, you will be required to submit a 2 month progress report. Where appropriate, these progress reports will be based on the project timetable and milestones.
Project management and governance
All project proposals should include details of how the project will be managed. For projects involving a number of institutions or component parts, effective project management is essential to ensure the work is completed within the planned timeframe. You should set out how joint applicants in different institutions will communicate and monitor progress of the project.
It is expected that all primary studies have a study steering committee (SSC). Please state in this section if you are going to have an SSC or, if not, you must explain your reasons for not doing so. Please note that if an SSC is not proposed, that decision will be reviewed by referees and the Research Funding Board and it is possible the programme may require that an SSC is established.
Ethics / Regulatory Approvals
Outline any ethical and/or other regulatory issues, and arrangements for handling them. The Programme expects applicants to follow ethical guidelines appropriate to the study and setting proposed. We will scrutinise ethics arrangements as part of the assessment of applications. Applicants must either comply with the Economic and Social Research Council’s (ESRC) research ethics framework or obtain approval via the National Research Ethics Service.
(Note that work outlined in your application/protocol must adhere to the UK Policy Framework for Health and Social Care Research).
Patient and Public Involvement
Note that your description of how patients and the public have been involved in developing this proposal, and how they will be involved in the proposed research, should be captured in the three specific Patient and Public Involvement (PPI) questions asked elsewhere in the application form. Although you are encouraged to include information about PPI activities within the Detailed Research Plan upload, there is no requirement to repeat or duplicate the responses to the three specific PPI questions. In rare cases where proposals do not involve patients or the public, clear justification must be provided, in response to the third PPI question.
INVOLVE has issued guidance for researchers about involving patients and the public in research, as well as about payment and support, including the Briefing Notes for Researchers and the Payment resource centre
Project / research expertise
Outline the particular contribution each member of the team will make to the project and the particular contribution that collaborators are intended to make. In addition, please give details of supervision arrangements for junior staff involved.
You should outline staff numbers and grades, timescales, equipment purchases, etc. that you are requesting funding for. If you propose to purchase expensive medical or other equipment, justify fully why you are not proposing to lease it, since this is the DH preferred option.
Please also provide details of collaborators and how they have aided the development of the proposal. Letters of support from collaborators should be provided as uploads. Where appropriate this should include a letter from the provider of the intervention costs.
If applicable you must also provide an explanation and justification of the NHS Support Costs and Excess Treatment Costs, or non-NHS support costs associated with this proposal including, if applicable, an explanation of the basis on which these costs have been estimated.
Success criteria and barriers to proposed work
Please set out the measurements of success you intend to use, the risks to the proposed research and how you intend to mitigate against them.
ATTACHMENT 2: Flow Diagram
In order to submit a Stage 2 application to the programme you must upload a diagram (single-side of A4), as a separate .PDF file, for submission with your application form.
The diagram should illustrate the study design and the flow of participants (if appropriate). If the project consists of more than one work package, consider a diagram that conveys the sequence and timing of research packages as well as how the work packages are linked.
Please ensure diagrams are large and clear enough for them to be projected as a slide at the committee meeting.
ATTACHMENT 3: References (maximum 1 pages of A4)
List all references cited in the full project description, using the Vancouver referencing conventions.
ATTACHMENT 4: 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 5: Logic Model
Please upload a logic model to support your proposed research if appropriate.
Acknowledge, review and submit
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. The ICMJE criteria for conflict management can be used as a guide. If in doubt, you should err on the side of disclosure.
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.
Checklist of information to include when submitting a NIHR stage 2 research application
- Applicants should click the check boxes to indicate that they have included the necessary information prior to submitting their application.
- Appropriate and relevant involvement of patients and the public
- A good quality Plain English Summary
- A clear description of team member roles and contribution
- A clear scientific abstract
- A clear description of the changes from first stage (if applicable)
- A flow diagram (where appropriate) illustrating the study design / flow of participants (document upload)
- A full and accurate detailed budget breakdown
- A clear justification of costs / value for money
- References (maximum 1 page of A4 - document upload)
- A clear Detailed Research Plan outlining the study design, methods, dissemination etc. (document uploads)
- Letters of support (document upload)
- The support and agreement from the necessary supporting roles / signatories