PHR Stage 2 Guidance notes for 21/36 mental health and wellbeing among young women
Please note: these are application form guidance notes for Stage 2 Applications specifically to the 21/36 call for Application Development Award - Mental health and wellbeing among young women.
Application summary information
Contacting (host) organisation
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 contracting (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 contracting (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 firstname.lastname@example.org before submitting your application.
It is sufficient to put ‘Application development awards - mental health and well-being among young women aged 12-24’.
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 January 2022. Teams will be expected to be contracted and commence the project during January 2022.
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.
Total (stage 2) NHS support and treatment costs or external (not NHS) intervention costs
Automatically populated from detailed budget section.
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 not, 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 Management Information System (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 terms and conditions, 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.
Patient and public involvement (PPI) co-applicants
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. They are not required to provide a full Curriculum Vitae (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, service users 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, being a carer - 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
For further information please access the 'Public Co-Applicants in Research' guidance.
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 six 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 Digital Object Identifier (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
Please click the ‘Add’ button and select the 'Joint Lead Applicant Role' drop-down option, and enter their details (if applicable). You are not required to complete the 'Justification for Joint Lead Applicant' boxes on the online form. However, as they are mandatory fields please enter N/A into each box.
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 or social care 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, including public 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 co-applicants to complete their section.
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:
- Administrative authority or finance officer
- 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.
- 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 and care 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.
Please ensure that the required signatories (above) are aware of the statements of responsibility that they are agreeing to by making an electronic signature.
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 commissioning brief.
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, 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 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 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.
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 (limit 6,000 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.
Patient and public involvement (PPI)
Please describe how patients/service users, carers 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/service users, carers and the public will be actively involved throughout the proposed research, including any training and support provided (limit 3,500 characters)
Patients, carers, service users and the public can be involved in every stage of a research project, from developing a proposal through to dissemination and evaluation.
PPI approach, management and support
- Explain why your approach to patient and public involvement is appropriate for this proposal. In your description you will need to say who will be involved and why.
- Please use this opportunity to describe how you plan to manage and coordinate the patient and public involvement activities in your project.
- Describe how you will support and enable patients/service users, carers, the public and members of relevant communities to contribute to your research (e.g. access, payments, training).
- We would also encourage you to outline plans for the capturing, evaluating and reporting the impact of patient and public involvement activities.
INVOLVE has developed guidance both on how patients and public can be involved in its guidance notes for researchers. The processes, procedures and values necessary to support this involvement are explained in more detail on the INVOLVE website.
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 are available.
A summary of PPI activities
Please provide a summary below of the proposed PPI activities embedded throughout the research project lifecycle. Please clearly signpost to other sections of the 'Detailed Research Plan' where the PPI is described further in relation to the relevant project stage e.g. dissemination, intervention design, data collection, analysis.
In rare cases where proposals do not involve patients/service users, carers 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 and/or social care. For example, where appropriate, describe the likely cost savings or benefits in terms of numbers of patients treated, treatment times, service users or carers supported 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 and Social Care. 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 1 June 2020 then its second year starts 1 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).
- Payments are not able to made in advance of need and, if funded, your payments will be made in accordance with your application budget. Please therefore ensure that your planned costs are included in the budget year in which they are most likely to be incurred.
- 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, including costs for social care research 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.
- 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 organisation
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 - please note that the NIHR will not fund more than 100% of an applicant’s time across multiple NIHR projects/awards and this fact will be checked prior to contracting. If you are unsure about this requirement or have any questions please contact the appropriate NIHR research funding programme.
The Apprenticeship Levy can be included in the salary costs from 1 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 and 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.
- Equipment. 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 £1000 to include VAT and any associated software. 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.
- Consumables. 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 individual travel, out of pocket expenses, payment for time and any relevant training and support costs. Costs related to study participants should not be itemised here.
INVOLVE have produced a number of useful payment-related resources.
If voluntary, charity or community groups are supporting the research via activities such as facilitating contact with potential participants, contracting research activities or providing advice, an adequate budget must be included to compensate for their time and 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, costs associated with inclusivity (which may include, but are not limited to justified translation of research participant material into other relevant languages), 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/DHSC 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 the 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 read attributing the costs of health and social care research and development (AcoRD).
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 six A4 pages
- 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 – Mental health and wellbeing among young women aged 12-24’ 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.
- Research questions
This scheme aims to provide funding for underpinning development work that will add to the current knowledge base and will ultimately support and inform applications to a pending commissioned call on interventions to promote mental health and wellbeing among young women that will launch late 2021/early 2022. This aim should be the basis of your research question.
- Research plan / methods
Please refer to the commissioning brief accessible from the funding opportunity webpage when writing your research plan. Please ensure you consider and articulate how this underpinning development work will link to and aid a future application to the future commissioned call.
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.
Possible areas of work may include (but are not limited to):
- Work to understand what data are collected on young women’s use of services, programmes and interventions to prevent and reduce mental health problems. For example, data collected by services dedicated to the provision of mental health support, services primarily for women or young women or other statutory organisations for whole populations such as CAMHs, local authority and third sector services.
- Secondary analyses of existing data.
- Underpinning research such as epidemiology. For example, investigations of prevalence within specific groups of young women or broader epidemiological assessments that may inform intervention research. This could include attention given to the scale, types and pattern of mental health problems, regional variations, ethnicity, socio-economic group, age group or causative factor.
- Development of networks or partnerships to support intervention research. For example, across or within particular geographical areas or services that young women access or settings where young women gather.
- Local or regional needs assessments to identify priorities for future research.
- Analysis of how current interventions to prevent or reduce mental health problems in the general population or other specific population groups may be applied to young women and consideration of possible new approaches.
- Analysis of how current interventions, where the primary focus of the intervention is not necessarily on improving mental health, could be evaluated to understand the impact on wellbeing and mental health.
- Identification and engagement of relevant stakeholders. For example, with specific communities and groups of young women, families and carers, policy makers, service providers.
Applicants should ensure that the development work includes recognition of future possible interventions and approaches to promote good mental health and prevent or reduce mental health problems among young women.
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. 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 they be engaged with?
- Outcome measures: please state and justify the primary and secondary outcome measures. Validated surrogate markers are acceptable where appropriate. Details should include justification of the use of outcome measures where a legitimate choice exists between alternatives, the proposed duration of the intervention and frequency and duration of follow up.
- Methods for data collection: please state the method of data collection, including qualitative methods where appropriate.
- Data and statistical analysis: please provide details of how data will be analysed. Clearly state the purpose of any statistical analysis. The proposed type and frequency of analyses must be stated.
- 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 - 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
- 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. Costs associated with inclusivity, which may include, but are not limited to justified translation of research participant material into other relevant languages, would be expected and where appropriate should be included in the detailed budget section under ‘Other Direct Costs’. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.
The NIHR supports the Researcher Development Concordat which recognises the critical role of research and innovation in delivering the UK’s ambitious economic and industrial strategies, and aims to set the gold standard in researcher development and use it as a competitive advantage. NIHR research applicants should understand the concordat and consider this when completing their application.
Helpful information can also be found on the INVOLVE website Diversity and Inclusion pages. and the NIHR Promoting equality, diversity and inclusion in research pages.
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 and how this will lead to future evaluative work. It will also be used by the NIHR to inform ongoing discussions in this area. The output will include a written report which will be published on the NIHR Journal’s website. This report will be delivered by June/ July 2022.
What do you intend to produce from your research?
In addition to that stated above, 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 or social care intervention.
How will you inform and engage patients/service user, carers, NHS, social care organisations and the wider population about your work?
Describe who you need to communicate with within this research, and your plans for engaging relevant audiences. For impact, it is unlikely that simply making outputs available will be sufficient. Please consider, and outline the active approach you will take to engaging key parties, or identify the process you will use to identify them and formulate an engagement plan. NIHR Dissemination guidance
How will your outputs enter our health and care system or society as a whole?
Describe the process by which the research will enter the health, social care or public health environment, including how your outputs will be acknowledged, selected and introduced for use in the health and care service or wider society. Where possible consider how the work will be able to be adopted and implemented longer term. Please describe the proposed route to market (commercial or non-commercial) for your outputs. Describe who is needed to take it forward and the relationship you currently (or propose to) have with these parties. If your outputs are likely to be commercially exploitable, please include details on how you plan to develop this.
What further funding or support will be required if this research is successful (e.g. from NIHR, other Government departments, local government, charity or industry)?
Consider what investment or support may be needed at the end of this project to maximise impact. Not all projects will require this but if so, plans should be linked to the responses in points 2 and 3 above.
What are the possible barriers for further research, development, adoption and implementation?
Describe the difficulties that may be faced in generating impact from your research. These may be difficulties you will face yourself, or challenges faced by those in the implementing context (e.g. clinicians).
- Will the proposed research use data, technology, materials or other inventions that are subject to any form of intellectual property protection (e.g. copyright, design rights, patents) or rights owned by another organisation(s)? If yes, provide brief details including how such third party IP will be accessed (e.g. collaboration agreement, drug supply agreement).
- What are the key current and future barriers to uptake of any likely output or innovation directly in health and care services, through commercial exploitation or other means, e.g. potential regulatory hurdles?
- What are the challenges for getting your research implemented in terms of acceptability, accessibility and feasibility? How will you address these?
What do you think the impact of your research will be and for whom?
Describe the impacts you aim to achieve as a direct result of the project and those which are anticipated longer term. Impacts may include, but are not restricted to - patient/service user/carer benefit; health or social care staff benefits; changes in NHS or care services (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 January 2022 – end June 2022 with a final report being delivered by 1 July 2022.
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 two 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 Funding Committee 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.
- 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. You can find examples of the activities a PPI lead might undertake on the NIHR website.
INVOLVE has issued guidance for researchers about involving patients and the public in research, as well as about payment and support.
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 DHSC 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.
Attachment 3: logic model
Where appropriate please supply a logic model or equivalent.
Attachment 4: references (maximum 3 pages of A4)
List all references cited in the full project description, using the Vancouver referencing conventions and include the DOI of the main related publication.
Attachment 5: letters of support
Please upload any letters of support from study collaborators or partners.
Attachment 6: papers in press
Supporting research papers not yet published or publically available should be provided.
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 and 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.
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 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/service users, carers 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 3 pages of A4 - document upload)
- A clear Detailed Research Plan outlining the study design, methods, dissemination etc. (document upload)
- Logic model or equivalent (document upload)
- Letters of support (document upload)
- Papers in press (document upload)
- The support and agreement from the necessary supporting roles / signatories